ID

38799

Beskrivning

A Study of Multiple Doses of LY2922470 in Participants With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01867216

Länk

https://clinicaltrials.gov/show/NCT01867216

Nyckelord

Versioner (1)
  1. 2019-11-04 2019-11-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 november 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Diabetes Mellitus, Type 2 NCT01867216

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT01867216

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
Beskrivning

Gender | Female infertility | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3]
C0011860
have a glycated hemoglobin (hba1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
Beskrivning

Diabetes Therapy unchanged | Exercise | Metformin | Metformin Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0442739
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0025598
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0332197
have a screening body mass index (bmi) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Beskrivning

Blood Pressure Acceptable | Pulse Rate Acceptable | Blood test result Acceptable | Urine test results Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0232117
UMLS CUI [2,2]
C1879533
UMLS CUI [3,1]
C0849535
UMLS CUI [3,2]
C1879533
UMLS CUI [4,1]
C0851020
UMLS CUI [4,2]
C1879533
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
are currently participating in another clinical study or completed one in the last 30 days
Beskrivning

Study Subject Participation Status | Clinical Trial Other Completed

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0205197
have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
Beskrivning

Heart Disease | Lung disease | Liver disease | Kidney Disease | Stomach Disease | Brain Disease | Medical Problem Causing Risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0038354
UMLS CUI [6]
C0006111
UMLS CUI [7,1]
C1254481
UMLS CUI [7,2]
C0678227
UMLS CUI [7,3]
C0035647
have electrocardiogram (ecg) readings that are not suitable for the study
Beskrivning

Electrocardiogram Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1548788
are infected with hepatitis b or hepatitis c
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
are infected with human immunodeficiency virus (hiv)
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
have donated blood equal to or more than 500 ml within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
Beskrivning

Blood Donation Quantity Timespan | Plasma Donation Timespan | Blood Donation Any Timespan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
UMLS CUI [2,3]
C0872291
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1552551
UMLS CUI [3,3]
C0872291
Tillbaka till toppen

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01867216

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Diabetes Mellitus, Non-Insulin-Dependent
Item
must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
have a glycated hemoglobin (hba1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
boolean
C0474680 (UMLS CUI [1])
Diabetes Therapy unchanged | Exercise | Metformin | Metformin Absent
Item
do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
boolean
C3274787 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Body mass index
Item
have a screening body mass index (bmi) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Blood Pressure Acceptable | Pulse Rate Acceptable | Blood test result Acceptable | Urine test results Acceptable
Item
have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
boolean
C0005823 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0232117 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0849535 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
C0851020 (UMLS CUI [4,1])
C1879533 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial Other Completed
Item
are currently participating in another clinical study or completed one in the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Heart Disease | Lung disease | Liver disease | Kidney Disease | Stomach Disease | Brain Disease | Medical Problem Causing Risk
Item
have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0038354 (UMLS CUI [5])
C0006111 (UMLS CUI [6])
C1254481 (UMLS CUI [7,1])
C0678227 (UMLS CUI [7,2])
C0035647 (UMLS CUI [7,3])
Electrocardiogram Inappropriate
Item
have electrocardiogram (ecg) readings that are not suitable for the study
boolean
C0013798 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C
Item
are infected with hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
are infected with human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Blood Donation Quantity Timespan | Plasma Donation Timespan | Blood Donation Any Timespan
Item
have donated blood equal to or more than 500 ml within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
C0005794 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial